Experience in Quality Control performing analytical methods such as Compendial testing, FTIR, UHPLC, Spectroscopy, CE-SDS, Cell Culture, ELISA, PCR (ddPCR & qPCR), Potency, FFU, PFU, and Flow Cytometry.
Experience with providing technical advice and support for client and regulatory audits/inspections via meetings/teleconferences.
Experience managing Stability programs
Experience managing Raw Material qualification activities
Experience onboarding new methods into QC (Method Transfers, Qualifications, and Validations)
Knowledge of cGMP manufacturing and quality systems within an FDA-regulated environment and ICH quality guidelines.
Technical Skills: Proficiency in analytical techniques (e.g., ELISA, HPLC/UPLC, qPCR/ddPCR, spectroscopy, cell-based assays); GMP documentation, instrument maintenance; basic programming or data analysis tools.
Regulatory/Quality: Knowledge of governmental regulatory guidelines relating to the manufacturing of biologics (cGMP, ICH guidelines, and QA/QC systems); Experience with Quality Management Systems to document investigations, change controls, and CAPAs.
